Skysona Purple Book BLA 125755
- BLA number
- 125755
- Proprietary names
- Skysona
- Proper names
- elivaldogene autotemcel
- Applicant
- Genetix Biotherapeutics Inc.
- Center
- CBER
- First observed release
- 2022-09-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Skysona | elivaldogene autotemcel | 351(a) | 2-30 × 10^6 CELL/ML | Injection | Intravenous | Bag | Rx | Licensed | 2022-09-16 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-03-01 | U | 001 | Skysona | 351(a) | Rx | Genetix Biotherapeutics Inc. |
| 2023-03-01 | U | 001 | Skysona | 351(a) | Rx | Bluebird Bio Inc. |
| 2022-10-01 | U | 001 | Skysona | 351(a) | Rx | Bluebird Bio Inc. |
| 2022-09-01 | N | 001 | Skysona | 351(a) | Rx | Bluebird Bio Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-09-01 | 001 | Skysona | 351(a) | Rx | Licensed | 2022-09-16 |